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news.NexMed, a CRO with a pipeline of product candidates based on the NexACT technology, has received screening acceptance letter from Health Canada in connection with its new drug submission (NDS) for Vitaros, a topical treatment for erectile dysfunction.
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The acceptance letter confirms that the Chemistry, Manufacturing and Controls (CMC) response filed by NexMed is acceptable for the final, 150-day review cycle, during which regulatory reviewers are expected to determine the final approvability of the product for marketing in Canada.
NexMed stated that based on the date of acceptance, a final approval decision is expected by the end of November 2010.
Bassam Damaj, president and CEO of NexMed, said: “Receipt of the acceptance letter is an important milestone in the development of Vitaros and we remain positive about the possibility for eventual product approval.
“As such, we anticipate utilising our Canadian application as the basis for filing new marketing applications in other international markets.”